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Alkermes plc (ALKS) Announces Alignment With FDA on Plans for Pivotal Program for ALKS 5461 for Major Depressive Disorder



10/9/2013 10:51:48 AM

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DUBLIN--(BUSINESS WIRE)--Alkermes plc (NASDAQ: ALKS) today announced that it has successfully completed its End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), and the company plans to advance ALKS 5461 into phase 3 development in early 2014. Alkermes is developing ALKS 5461 for the treatment of patients with major depressive disorder (MDD) who have inadequate response to standard therapies.

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